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Frequently Asked Questions for Pharmacists on Medication Guides

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REVISED ANTIDEPRESSANT MEDICATION GUIDES
On May 2, 2007, the FDA proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidality in young adults ages 18 to 24 during inital treatment. Read more here.

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Q: What should pharmacists do in cases where Medication Guides are not being provided by the manufacturer as required by the Federal Food, Drug, and Cosmetic (FD&C) Act?

A: Under the Federal Food, Drug, and Cosmetic (FD&C) Act, Food and Drug Administration (FDA) requires that Medication Guides be dispensed with products the agency deems a serious and significant public health concern. Medication Guides provide consumers with information about the risks and benefits of these drugs and are necessary for patients to use these products safely and effectively.

FDA is interested in receiving reports about all instances in which manufacturers, distributors, or packers are not complying with the Medication Guide distribution requirements as set forth in Title 21, Code of Federal Regulations (CFR), section 208.24, Distributing and dispensing a Medication Guide.

The regulation requires manufacturers, distributors, or packers to provide authorized dispensers with Medication Guides – or the means to produce Medication Guides – in sufficient numbers to provide one to each patient who receives the drug. The manufacturer is responsible for ensuring that pharmacists have the Medication Guides they need when dispensing these drugs to consumers.

Problems related to the availability of Medication Guides are a labeling concern to FDA, and pharmacists are often the first to become aware of these problems. Voluntary reporting by pharmacists of these instances would assist FDA in ensuring manufacturer, distributor, and packer compliance with the Medication Guide regulatory requirement.

In addition to reporting to FDA, the agency advises pharmacies to contact the manufacturers directly to discuss problems associated with the availability of Medication Guides.

More information is available at www.fda.gov/medwatch/report/hcp.htm. Reports can also be made by phone at 1-800/FDA-1088.

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Q: For which drugs does the FDA require distribution of a Medication Guide?

A: Medication Guides are deemed part of a drug’s FDA-approved labeling, and must be distributed to patients with the medication.

The FDA maintains a list of drugs for which Medication Guides, and copies of the Medication Guides, at: http://www.fda.gov/cder/Offices/ODS/labeling.htm

Read more about Medication Guides in this April 2006 Drug Topics article: http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=314981

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PLEASE NOTE: FDA to Hold a Public Hearing on Use of Medication Guides - On June 12-13, 2007, the FDA's Center for Drug Evaluation and Research (CDER) will hold a public hearing to obtain feedback on the Medication Guide program, which provides for the distribution of FDA-approved written patient information for certain drug and biological products that pose serious and significant public health concerns. Click here to view the FDA public hearing notice. ››

 

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